Our Services

Foreign medical device and cosmetics manufacturers or distributors / exporters that do not have a Brazilian branch must appoint a Brazilian Registration Holder – BRH.
This company acts as a link between your company and National Health Surveillance Agency – ANVISA and is responsible for your registration in Brazil. Dunnia Group, with offices in Brasilia – BRAZIL and Orlando, Florida – USA, can act as your BRH.

How to enter the Brazilian market immediately, reduce the cost of registration and still have the freedom to choose your importers and distributors?

The Dunnia Group simplifies the entry of foreign products Medical devices, cosmetics and food products in the Brazilian market, making them (your company’s products) more competitive.

The first step of this process is product registration with the National Health Surveillance Agency (ANVISA) on behalf of the Dunnia Group. We possess all authorizations, permits and certifications for registering products with ANVISA.

We are responsible for maintaining the registry during its term (5 years) with exclusive use of your company and clients (distributors) specified by you.

Furthermore, if our client has interest, Dunnia Group has all the necessary documentation to perform direct imports and distribution.

The Dunnia Group simplifies the entry of foreign products Medical devices, cosmetics and food products in the Brazilian market, making them (your company’s products) more competitive.

The first step of this process is product registration with the National Health Surveillance Agency (ANVISA) on behalf of the Dunnia Group. We possess all authorizations, permits and certifications for registering products with ANVISA.

We are responsible for maintaining the registry during its term (5 years) with exclusive use of your company and clients (distributors) specified by you.

Furthermore, if our client has interest, Dunnia Group has all the necessary documentation to perform direct imports and distribution.

Faster Results

We’re already approved by ANVISA, so we don’t need to wait for permits and licenses. This means an alleviation of at least 12 months in the process of entry into the Brazilian market.

Freedom to Replace Importers / Distributors

As holders of registration of the products your company has complete freedom to negotiate with importers / distributors, ensuring greater flexibility and security to your business. For every importer identified, Dunnia will give permission to import using Dunnia’s product registration. Your company has TOTAL control of the operation.

Support and legal certainty

Dunnia Group respects the principles of Brazilian and US law, the integrity of Lawyers, ethical and moral principles and American anticorruption legislation.

Agility in the Release of Registrations

With over 21 years of experience in the regulatory area, our team has acquired the know how necessary to drive the process of product registration with efficiency and agility.

Summary

Product registration under the name of Dunnia Group with all the rights due exclusively to the contractor and his/her authorized representatives. In other words, the registry is YOURS;

Agility; It is not necessary to wait years for the opening and registration of the company in Brazil;

The registration will be valid for 5 years;

You do not need to be physical CONTRACTING company (Moulds ANVISA) in Brazil, which means economy in regulatory terms, (starting a business, physical structure, framework for technical assistance, technical manager, rent, staff, etc.) easily exceeds USD 35,000.00 monthly. After 5 years this will represent USD 2,100,000.00;

You may have representatives in all Brazilian states using the registration on behalf of Dunnia;

Afterward, if contractor was to create a branch in Brazil and register the product under their own name, there will be no legal fees towards the regulatory procedure.

BRAZIL GMP (BGMP) - Quality System Compliance

Companies that want to sell medical devices or IVD products in Brazil must comply with Brazilian Good Manufacturing Practice (GMP) quality system requirements. With ANVISA’s release of RDC 15/2014, B-GMP certification is only required for manufacturers of Class III and IV medical devices and Class II, III and IV IVDs.

With offices in Brazil and the USA, Dunnia Group knows how to upgrade your existing QMS to comply with Brazilian GMP requirements. In the last 4 years we approved factories in the USA, Japan, China, South Korea, Taiwan, France, Italy, Germany, Israel, the UK and India.

Our Services include:

Pre-inspection in loco; (in-house);

Process Celerity – average approval in 6 months.

PRODUCTS REGISTRATION

The products registration at ANVISA is a complex process that expends company time and money, which sometimes allocates professionals from other departments to perform this kind of work.

Dunnia Group has over 21 years strong expertise in product registration, with a multidisciplinary staff composed of professionals with comprehensive experience on industry routine, focusing their efforts in order to allow the shortening of the process as requested by the clients while adhering to the specified standards by ANVISA. The result is the fast obtainment of definitive registrations, essential to the manufacture, importation and marketing of products.

Why to register products with Dunnia Group?

We are a Consulting company with over 21 years experience;

We have thousands of registered process;

Dunnia Group develops and follows the whole products registration project with your company;

We operate in all fields of products subject to Health Surveillance rules;

Dunnia Group is located in Brazil and the USA as well; our contracts / Agreements follow the US Law.

Our client portfolio is composed of small businesses up to multinationals;

The work is performed by experienced professionals and with strong know-how on product registration;

Our staff registers and follows, in loco (Our Brazilian Office is located few minutes from ANVISA Headquarter);

Our work experience and methodology result in valuable time and resources savings on the obtainment of your registrations;

Greater profitability for your company so it can offer new products to the market in a shorter time.

Tag Cloud

Established in 2003, our main office is located in Brasilia-DF (Brazil) near ANVISA headquarters and branch in the city of Orlando, Florida (USA). We specialize in regulatory affairs (Operating Permits – AFE, Good manufacture Pratices – GMP and Product registration with ANVISA).

Dunnia Group offers combined solutions for regulatory matters, import and distribution to Brazil in one place.